FDA Adverse Event
Injury
Summary report: N
NATURALYTE
MDR report key: 4091233
·
Received June 27, 2014
Report
- Report Number
- 1225714-2014-05363
- Event Type
- Injury
- Date Received
- June 27, 2014
- Date of Event
- October 26, 2012
- Report Date
- May 27, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K070177
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE EVENT (CARDIOVASCULAR) OF TWO EVENTS REPORTED FOR THE SAME PT INVOLVING THREE SEPARATE PRODUCTS; ASSOCIATED MDRS # 1225714-2014-05362, 1225714-2014-05363, 1225714-2014-05364, 1225714-2014-05365, 2937457-2014-01347 AND 2937457-2014-01348.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PLAINTIFF EXPERIENCED A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2012, AND A CARDIOVASCULAR EVENT IN (B)(6) 2006 AFTER THE USE OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 377270 | NATURALYTE | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |